BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE

    MDR report key: 10156239 · Received June 15, 2020

    Report

    Report Number
    1920898-2020-00678
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    June 3, 2020
    Report Date
    June 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    10885403421532
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070601. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200812519] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR BARREL DISCOLORED ON LOT # 9070601. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, BARREL DISCOLORED) WAS CAPTURED AND ADDRESSED APPROPRIATELY. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ INSULIN SYRINGE WAS "DARK" UP TO THE 5 UNIT MARK. THIS WAS NOTICED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER LEFT VOICEMAIL STATING THAT THE SYRINGES ARE DARK. I RETURNED CONSUMER'S CALL, SHE STATED THAT A SECTION OF THE SYRINGES ARE DARK UP TO THE 5 UNIT MARK. CONSUMER SAID SHE NOTICED IT ABOUT ONE WEEK AGO, ALOS SAID SHE DOES NOT RE-USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620074 BD INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE TRANSFUSION 9070601 10885403421532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other